Expert Advice Community

Guest

"Shall" statement

  Quote
Guest
Guest user Created:   Oct 16, 2019 Last commented:   Oct 16, 2019

"Shall" statement

I was wondering that how can we prove to the audit that a "shall" statement is fulfilled when there is no requirement in the standard about documenting the evidence of it?

0 0

Assign topic to the user

ISO 9001 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 9001 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Carlos Pereira da Cruz Oct 16, 2019

This is a question that often comes up during webinars. How to evidence something that ISO 9001:2015 does not compel to document?

This is why I believe ISO 9001:2015 is better understood from the point of view of an organization that had never implemented a quality system and is starting from scratch. Let me answer with an example. Consider an organization that has nothing written about risks. How can they evidence that risks were determined, evaluated and actions were taken?

Let us consider the process “Buy material”.

Can anyone order materials to a supplier? 

- No, only authorized functions
- Can you order a material from any supplier? 

No, only suppliers included in the Suppliers Approved List
- Can delivered materials be sent directly to production? 

No, only after a quality control done by the warehouse.
- Can non-conforming material be sent to production inadvertently? 

No, non-conforming material is labeled as non-conforming as is segregated to a special space.
- Come on people operate your process they can fail. 

Yes, they can fail but yo minimize that we defined competencies for each function, we select and train people according to those competencies

You see, these are things that an organization with a quality management system already implemented is already doing to avoid or reduce risks, without using that terminology. So, search for evidences like these. I’m sure you can find them if you put another kind of lenses.

The following material will provide you more information about auditing:

- Article - List of mandatory documents required by ISO 9001:2015 - https://advisera.com/9001academy/knowledgebase/list-of-mandatory-documents-required-by-iso-90012015/ (there is no shortage of mandatory records that can be used to check evidences by “triangulation”)
- Free webinar on demand – How to implement risk management in ISO 9001:2015 - https://advisera.com/9001academy/webinar/how-to-implement-risk-management-in-iso-90012015-free-webinar-on-demand/
- Enroll for free course - ISO 9001:2015 Foundations Course - https://training.advisera.com/course/iso-9001-foundations-course/
- book – Discover ISO 9001:2015 Through Practical Examples – https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/

Quote
0 0

Comment as guest or Sign in

HTML tags are not allowed

Oct 16, 2019

Oct 16, 2019

Suggested Topics